Expandable supportive bifurcated endoluminal grafts

• US 5,639,278 A
• Filed: 11/13/1995
• Issued: 06/17/1997
• Est. Priority Date: 10/21/1993
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Corvita Corporation (Boston Scientific Corporation)
• Inventors: Pinchuk, Leonard, Dereume, Jean-Pierre Georges Emile, MacGregor, David C.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/558,034
• Time in Patent Office: 582 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

An endoluminal graft which is both expandable and supportive is provided in a form suitable for use in a bifurcated body vessel location. The graft expands between a first diameter and a second, larger diameter. The support component is an expandable stent endoprosthesis. A cover, a liner, or both a cover and a liner are applied to the endoprosthesis in the form of a stretchable wall material that is porous, elastomeric and biocompatible in order to allow normal cellular invasion upon implantation, without stenosis, when the expandable and supportive graft is at its second diameter. The supportive endoluminal graft is preferably provided as a plurality of components that are deployed separately at the bifurcated body vessel location.

Claims

1. A multiple-component bifurcating expandable supportive endoluminal graft comprising:

a plurality of expandable supportive endoluminal components which are deployed individually at a selected location within a body vessel, each said supportive endoluminal graft component being radially compressible for endoluminal insertion and radially expandable for deployment at a desired location within a body vessel;

one of said expandable supportive endoluminal components is a trunk component, said trunk component including a tubular supporting member and a trunk liner positioned along said tubular supporting member, said trunk liner having a generally cylindrical body portion and at least two leg portions, each said leg portion defining a leg opening;

at least one other of said expandable supportive endoluminal components is a generally cylindrical supportive leg component; and

said generally cylindrical supportive leg component and one of said leg portions of the trunk component, when said leg component and trunk component are deployed within the body vessel, are telescopically positioned with respect to each other.

2. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive leg component has an end portion which, when deployed, is positioned within said leg opening of the trunk component.

3. The supportive endoluminal graft in accordance with claim 1, wherein said plurality of expandable supportive endoluminal components are self-expanding.

4. The supportive endoluminal graft in accordance with claim 1, wherein said plurality of expandable supportive endoluminal components are deployed by a radially expandable device.

5. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive component includes a generally cylindrical supporting member and a generally cylindrical liner secured therealong.

6. The supportive endoluminal graft in accordance with claim 1, wherein said trunk liner is a stretchable wall of essentially inert biocompatible material, said stretchable wall being attached to a portion of the internal surface of the trunk component tubular supporting member, said stretchable wall having a diameter size that expands with said trunk component tubular supporting member.

7. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the generally cylindrical supportive leg component is a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto at least the internal surface of the generally cylindrical tubular supporting member of the leg component.

8. The supportive endoluminal graft in accordance with claim 1, wherein said leg portions of the trunk liner extend longitudinally beyond said tubular supporting member of the trunk component.

9. The supportive endoluminal graft in accordance with claim 8, wherein said leg portions are separated from each other.

10. The supportive endoluminal graft in accordance with claim 1, wherein said leg portions of the trunk liner are longitudinally generally coextensive with said tubular supporting member of the trunk component.

11. The supportive endoluminal graft in accordance with claim 10, wherein an outside section of each of said leg portions of the trunk liner is secured to said tubular supporting member, while inside sections of each of said leg portions are secured to each other along an internal seam.

12. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive leg component, when deployed, is telescopically slidably positioned within one of said leg portions of the trunk component.

13. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the leg component and said trunk liner are each a stretchable wall made from a porous elastomeric material that provides a structure which allows normal cellular invasion thereinto from the body vessel when implanted therewithin.

14. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material of each stretchable wall is an elastomeric polymer.

15. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material of said stretchable wall is a polycarbonate urethane.

16. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material is coated with a thin layer of silicone rubber.

17. The supportive endoluminal graft in accordance with claim 5, wherein said trunk liner and said liner of the leg component are each a stretchable wall along the internal surface and the external surface of each tubular supporting component.

18. The supportive endoluminal graft in accordance with claim 1, wherein an exposed longitudinal end of said tubular supporting member extends longitudinally beyond and is not completely covered by said liner.

19. The supportive endoluminal graft in accordance with claim 17, wherein said tubular supporting member has a plurality of open areas therealong, and said stretchable wall along said external surface of the tubular supporting component is bonded to said stretchable wall along said internal surface of the tubular supporting component at locations defined by said open areas of the tubular supporting component.

20. The supportive endoluminal graft in accordance with claim 1, wherein said tubular supporting member has a plurality of open areas therealong, and an attachment component passes through one of said open areas of said tubular supporting component.

21. The supportive endoluminal graft in accordance with claim 1, wherein said tubular supporting component includes a plurality of wire strands with open areas therebetween.

22. The supportive endoluminal graft in accordance with claim 21, wherein said wire strands of the tubular supporting component are generally sinusoidally configured wire that is helically wound into the tubular supporting component, said wire defining therebetween said open areas of the tubular supporting component.

23. The supportive endoluminal graft in accordance with claim 21, wherein said wire strands of the tubular supporting component are shaped as intersecting elongated lengths integral with each other and defining said openings therebetween to form a mesh-shaped tubular supporting component.

24. The supportive endoluminal graft in accordance with claim 1, wherein the endoluminal graft is subjected to surface treatment for enhanced bicompatibility or for drug therapy.

25. The supportive endoluminal graft in accordance with claim 1, wherein said trunk component includes a projecting securement member.

26. A multiple-component bifurcating expandable supportive endoluminal graft comprising:

a plurality of expandable supportive endoluminal graft components which are deployed individually at a selected location within a body vessel, each said supportive endoluminal graft component being radially compressible and radially expansible;

one of said expandable supportive endoluminal graft components being a trunk component having a longitudinal axis, an internal surface disposed toward the longitudinal axis, and an external surface spaced outwardly from and shaped complementarily with said internal surface, said trunk component having a network of land areas with open areas defined therebetween,

two other of said expandable supportive endoluminal graft components being a generally cylindrical supportive leg component;

said trunk component having a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto at least one of said internal surface and said external surface of the tubular supporting component, said stretchable wall having an extension portion that extends beyond said tubular supporting component thereof; and

said extension portion of the stretchable wall is branched into at least two generally tubular leg portions of stretchable wall material, each said leg portion being sized and shaped to receive one of said generally cylindrical supportive leg components.

27. A method for implanting a multi-component bifurcating expandable supportive endoluminal graft, comprising the steps of:

providing a trunk component having a tubular supporting member and a trunk liner positioned along the tubular supporting member, the trunk liner having a generally cylindrical body portion and at least two leg portions, each leg portion defining a leg opening;

inserting the trunk component generally at a bifurcation site within a body vessel, and expanding the trunk component to engage a main vessel path of the vessel body;

providing a generally cylindrical supportive leg component which includes a tubular supporting member;

inserting the generally cylindrical supportive leg component into the body vessel at a location between a leg portion of the trunk component and a branched pathway associated with a main pathway of the body vessel, and expanding the leg component so as to be deployed at said location;

providing another generally cylindrical supporting leg component having a tubular supporting member; and

inserting the another generally cylindrical supportive leg component into the body vessel at a location between the other leg portion of the trunk component and another branched pathway associated with the main pathway of the body vessel, and expanding the component so as to be deployed at said location in order to form a bifurcated supportive endoluminal graft at a bifurcation site within the body vessel.

28. The method in accordance with claim 27, wherein each step of providing the leg component provides a leg component which includes a liner and a tubular supporting member, and each such leg component is deployed inside of a respective one of the leg portions of the trunk component, each of which is generally coextensive with the tubular supporting member of the trunk component.

29. The method in accordance claim 27, wherein said step of providing the trunk component provides leg portions that project beyond the tubular supporting member of the trunk component, and the steps of inserting the leg component insert a supportive stent respectively within the leg portions of the trunk component.